MAUDE Adverse Event Report: ORTHO DEVELOPMENT VUSION OS; INTERVERTEBRAL BODY FUSION DEVICE

Model Number	551-7309A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/07/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
An intervertebral cage was being inserted and was damaged.Attempts were made to retrieve the fragments, but due to their partial lodging within the vertebral space, one piece could not be recovered and was left in the patient.

• Brand Name: VUSION OS
• Common Device Name: INTERVERTEBRAL BODY FUSION DEVICE
• Manufacturer (Section D): ORTHO DEVELOPMENT; 12187 s. business park drive; draper UT 84020
• Manufacturer (Section G): ORTHO DEVELOPMENT; 12187 s. business park drive; draper UT 84020
• Manufacturer Contact: drew weaver ; 12187 s. business park drive; draper, UT 84020 ; 8015539991
• MDR Report Key: 23873810
• Report Number: 1722511-2025-00028
• Device Sequence Number: 5520317
• Product Code: MAX
• UDI-Device Identifier: 00822409020959
• UDI-Public: (01)00822409020959(17)300426(10)A412416
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K111965
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/22/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 551-7309A
• Device Lot Number: A412416
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/08/2025
• Initial Report FDA Received Date: 12/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/06/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Male